Moukharskaya, J., Abrams, D.M., Ashikaga, T., Khan, F., Schwartz, J., Wilson, K., . . . Ades, S. (2016). Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim. Supportive Care in Cancer, 24, 3085–3093. 

To investigate the effects of prophylactic antihistamine on colony-stimulating factor(CSF)–related bone pain

The study included observation and treatment phases. Patients receiving pegfilgrastim completed pain surveys during the observation phase. Patients who developed significant pain were randomized to loratadine 10 mg daily or a matched placebo for seven days beginning on the day of pegfilgrastim administration. Rescue analgesics were recorded. Bone pain was assessed at baseline and on day 8 during both study phases.

• N = 213 in observation phase, 46 in treatment phase   
• MEDIAN AGE = 59 years
• AGE RANGE = 22–90 years
• MALES: 33.9% (observation), FEMALES: 66.1% (observation)
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Various tumor types with breast and lung most common.
• OTHER KEY SAMPLE CHARACTERISTICS: All had baseline bone pain greater than or equal to 5 for study entry, and 25.7% were on non-NSAID analgesics at baseline.

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: USA

• PHASE OF CARE: Active antitumor treatment

• Observation and double-blind randomized treatment trial

• Brief Pain Inventory (BPI)
• Functional Assessment of Cancer Therapy–Bone Pain (FACT-BP)

Significant bone pain occurred in 30.5% of patients and worst pain score increased on average from 1.6 to 3.6 during the eight days following pegfilgrastim (p < 0.001). Patients receiving taxanes were more likely to develop significant pain (50.8% versus 23%, p < 0.001). There were no significant differences in baseline pain scores or change in pain scores between study groups. There were no significant differences between groups in analgesic use. Among patients receiving taxane, 90% benefited from loratadine, compared to 27.3%  in the placebo arm (p = 0.0008). Both study groups receiving taxanes showed increased worst pains scores from baseline.

In the total sample, antihistamine prophylaxis did not demonstrate a benefit for prevention of CSF-induced bone pain. Findings suggest that there may be some effects for patients receiving taxanes; however, the sample size is too small to draw firm conclusions.

• Small sample (< 100)
• Measurements used were designed to measure chronic pain rather than the acute episodic pain associated with CSFs. Pain was measured only at two time points. Some data regarding analgesic use were missing.

This study did not show any benefit of antihistamine for prevention of CSF-related bone pain. Findings suggest that further research in this area is needed, and specific examination of any benefits in patients receiving taxanes should be further investigated.